NCT04720365|Recruiting
Medico-economic Evaluation Rehabilitation by Serious Games at Home for the Management of Patients With Parkinson's Disease Suffering From Gait and Balance Disorders
PARKGAME_ECO
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PARKGAME_ECO
Sponsor study identifier
interventional
80
1 country
4
Study Start
February 15, 2023
Actual (reported)Primary Completion
February 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a multi-center, randomized, open-label, multi-center, randomized controlled study of 80 Parkinson's disease patients with gait and balance disorders in which 40 patients will be treated with serious games, in addition to their usual care, for 12 months and 40 patients will be treated with their usual care during this period. This study will be conducted in 4 centers, all of which are expert in the management of these patients. After randomization, each patient in the "Intervention-Rehabilitation through Toap Run" group will have to complete 2 to 3 sessions per week at home with the serious game "TOAP RUN" using the Kinect® system for 1 year.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 29, 2020
Actual (reported)January 22, 2021
Actual (reported)February 15, 2023
Actual (reported)February 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The incremental cost-utility ratio at 12 months for the management of patients with Parkinson's disease using therapeutic games
The result criterion is the additional cost in euros of a QALY gained. The QALY will be calculated from the utilities derived from the EuroQuality scale of life-5 dimensions EQ5D-3L.
at 12 months for the management of patients with Parkinson's disease using therapeutic games
The frequency of falls
Through study completion, an average of 24 months
The incremental cost-effectiveness ratio of Toap Run therapeutic gambling management compared to usual management.
Through study completion, an average of 24 months
Cost-effectiveness ratio of falls prevention
Through study completion, an average of 24 months
Criterion for the cost-utility ratio
Through study completion, an average of 24 months
The budgetary impact of Toap Run
Through study completion, an average of 24 months
Patients randomized in the "play-based rehabilitation" group will perform 2 to 3 gambling rehabilitation sessions at home using the Kinect® system linked to the Curapy.com platform for 12 months.
Patients randomized in the "usual care" group will have their usual rehabilitation care provided by their physiotherapist.
usual re-education treatment by their physiotherapist
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Chu Bordeaux
Bordeaux, 33076, France
Chu Lille
Lille, 59037, France
Marie-Laure WELTER, Professor
Rouen Uiniversity Hospital
First Submitted
December 29, 2020
First Posted
January 22, 2021
Study Start
February 15, 2023
Actual (reported)Primary Completion
February 1, 2029
Contact the study team to confirm eligibility.
Gh Pitie Salpetriere
Paris, 75013, France
Rouen University Hospital
Rouen, 76031, France
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 6, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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